- Office hours 5 days. 8am – 4.30pm
Job Scope
• Responsible to review and approve the Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluate and approve discrepancy related to qualification/validation protocols in order to guarantee documentation of the incidents and identification of corrective actions.
• Support collaboration and participations in projects as Quality Representative for Quality Systems and Validation.
• Provide validation expertise, oversight and support for the development (or modification phases) of Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification.
• Ensuring the information contained in approved qualification/validation document(s) is understandable and defendable during inspection.
• Provide quality oversight on the Quality Control validation maintenance activities and Master Validation Plan.
• Support in multisite initiatives to ensure harmonization of Quality Systems and qualification/validation related activities between the plants.
• Build strong partnership with all other departments to ensure open communications and acceptance
• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
• Any other duties as assigned by Manager/ Supervisor.
Education and Experience Requirements
Requirements
- Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
- Minimum 3 relevant years of experience in QA/QC and GMP Compliance
- Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
- Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
- Proven track record of continuous improvement in quality operations or manufacturing.
All qualified applicants, please send in your resume to: [email protected]
Alex Goh Hock Leong (R1763413)
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